Graduate Certificate in Medical Devices Regulatory Affairs

Coverage:

  • The history and evolution of the regulatory profession and the role of the regulatory professional throughout the product lifecycle
  • Foundational knowledge and the core competencies of regulatory professionals working in industry, regulatory agencies, research and other environments
  • Fundamentals of global medical device regulation, including identification of regulatory agencies and processes in major regulatory systems
  • Device regulation in the United States, European Union, ASEAN countries, China and Asia-Pacific
  • Quality and compliance
  • Critical thinking and practical application of regulatory knowledge
  • Global regulatory pathways and submission processes